End-Stage Kidney Disease (ESKD)
Conditions
Keywords
Hemodialysis (HD), Thrombosis, Bleeding, Blood clots, Chronic Kidney Disease (CKD)
Brief summary
This study will evaluate three Investigational Medicinal Products (IMPs) called REGN9933, REGN7508, and REGN9533. The study is focused on participants with End-Stage Kidney Disease (ESKD) treated with hemodialysis and standard anticoagulant treatment, such as heparin, to reduce the risk of blood clots as they can lead to serious health problems or be life-threatening. Because participants with ESKD who have hemodialysis have a higher risk of bleeding, the IMPs could be a meaningful new therapeutic option. The main aim of the study is to see what side effects may happen from taking REGN9933, REGN7508, or REGN9533. The study is looking at several other research questions, including: * How much IMP is in the blood at different times and * If the IMPs affect the ability of the blood to clot normally
Interventions
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Has ESKD and has regular adherence receiving HD 3 times per week as described in the protocol 2. Is receiving heparin (standard of care) anticoagulation, with no history of intolerability, during each dialysis session 3. Has adequate vascular access 4. Is clinically stable with no hospitalizations in the past 30 days prior to first screening visit as described in the protocol Key
Exclusion criteria
1. Has history of major bleeding (International Society on Thrombosis and Haemostasis \[ISTH\]) criteria) within the past 3 months prior to the first screening visit as described in the protocol 2. Has known bleeding conditions (eg, Hemophilia A, B or C, von Willebrand's disease) hemorrhagic tumor sites, or other conditions with a high risk for bleeding (eg, hepatic disease associated with coagulopathy) 3. Current use of oral anticoagulants (eg, warfarin, Direct Oral Anti-Coagulant \[DOACs\]) or dual antiplatelet therapy for clinical indication 4. Heart failure as classified by New York Heart Association (NYHA) class III or IV 5. Has a sustained uncontrolled hypertension as described in the protocol Note: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Up to approximately 78 days |
| Severity of TEAEs | Up to approximately 78 days |
Secondary
| Measure | Time frame |
|---|---|
| Concentrations of REGN9933 | Up to approximately 78 days |
| Concentrations of REGN7508 | Up to approximately 78 days |
| Concentrations of REGN9533 | Up to approximately 78 days |
| Change in activated Partial Thromboplastin Time (aPTT) | From baseline up to approximately 78 days |
| Change in Prothrombin Time (PT) | From baseline up to approximately 78 days |
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed